Category: Regulations

Mandated Long Clinical Trials Favor Trivial Incremental Drugs and Impede Magic Bullet Cures

(p. B1) AstraZeneca PLC’s new cancer research chief, José Baselga, wants the company to prioritize early-stage cancers over advanced disease when developing new cancer drugs. If successful, his unorthodox strategy could reap rewards for both patients—the potential to cure cancer is much greater when it is treated early—and company coffers.

The approach turns the tried-and-tested model of cancer drug development on its head. Typically, drug companies aim their new cancer drugs at patients with advanced forms of the disease who have exhausted other treatment options. Of the more than 30 new drugs for solid tumors approved for sale in the U.S. since the start of 2014, just two targeted early cancer.

That is largely because there is a clear-cut case for testing new drugs on patients with advanced cancer, as they don’t have other options. What’s more, measuring a new medicine’s effect in advanced cancer is straightforward: a meaningful extension in survival can usually be measured in months. Such patients are also often more willing to try experimental drugs, and regulators have smoothed the path for treatments that show they can prolong lives by delaying tumor growth in advanced cancer.

. . .

(p. B5) “One thing with early stage disease, you have to be able to cure patients,” said Daniel Chen, who spent more than a decade running cancer drug development projects at Roche Holding AG. “The majority of cancer drugs delay cancer growth, they don’t cure patients.” Dr. Chen is now chief medical officer at biotech startup IGM Biosciences Inc.

Running clinical trials could also be difficult, as it would involve persuading patients to try experimental drugs when they might already be cured.

Another challenge is measuring the drug’s effectiveness. In patients whose cancer is diagnosed and treated early, it would take years to determine whether a new drug meaningfully extended survival, making for very long clinical trials.

For the full story, see:

Denise Roland. “Drug Giant Tests Bold Tactic to Battle Cancer.” The Wall Street Journal (Tuesday, May 28, 2019): B1 & B5.

(Note: ellipsis added.)

(Note: the online version of the story has the date May 27, 2019, and has the title “Drug Giant Tries New Tactic to Fight Cancer.”)

FAA to Slightly Ease Regulation of Supersonic Test Flights

(p. B3) . . . , the FAA is poised to propose first-of-their-kind noise standards targeting takeoffs and landings of supersonic aircraft during test flights. Such maneuvers can exceed current standards for comparably sized conventional aircraft operating around airports. Some of the proposed supersonic jetliners are projected to be about one-third longer than the roughly 120-foot length of an older Boeing Co. 737.

Based on size, the FAA wants to permit more takeoff noise for supersonic craft than would be allowed under existing standards, but in every case no more than is now permitted for the largest wide-body airliners.

The FAA’s primary goal, according to Mr. Elwell, is to make sure “we don’t become a hindrance to the movement of this technology” into commercial applications.

Bombardier has restructured its aviation division over the past two years, highlighted by its joint venture with Airbus that put the European plane maker in charge of the production and sales of the 110- to 130-seat planes that the Montreal company had originally conceived as the CSeries. Those jets are now rebranded as the Airbus A220.

. . .

The anticipated regulations won’t deal with noise constraints at higher altitudes and supersonic speeds, where controlling sonic boom remains a major design and operational challenge requiring a new generation of quieter, more fuel-efficient engines. But for some time, supersonic proponents have lobbied Congress and tried to persuade the FAA to take preliminary steps to remove hurdles to development flights.

For the full story, see:

Andy Pasztor. “Supersonic Flights Poised for Return.” The Wall Street Journal (Tuesday, June 18, 2019): B3.

(Note: ellipses added.)

(Note: the online version of the story has the date June 17, 2019, and has the title “FAA Seeks to Enable Return of Supersonic Passenger Aircraft.”)

New Opiod Regulations Make Life Harder for Those in Severe Pain

(p. C4) There’s a great deal in “Dopesick” that’s incredibly bleak, but the most chilling moment for me was a quote from one of Macy’s journalist friends. Synthetic opioids had allowed this woman, despite a severe curvature of her spine, to lead an active life without risky surgery. She resented new rules that made it more onerous for her to get the pills. “My life,” she told Macy, “is not less important than that of an addict.”

For the full review, see:

Jennifer Szalai. “BOOKS OF THE TIMES; A Ground-Level Look At the Opioid Epidemic.” The New York Times (Thursday, July 26, 2018): C1 & C4.
(Note: ellipsis added.)

(Note: the online version of the review has the date July 25, 2018, and has the title “BOOKS OF THE TIMES; ‘Dopesick’ Traces the Opioid Crisis, From Beginning to Blow Up.”)

The book under review, is:

Macy, Beth. Dopesick: Dealers, Doctors, and the Drug Company That Addicted America. New York: Little, Brown and Company, 2018.

Fire Marshall Regulations Reduce Use of Hospital Hand Sanitizers, Helping Spread Dangerous Bacteria

(p. A11) With the use of alcohol-based hand sanitizer — often more effective and convenient than soap and water — it’s far easier to keep hands clean than clothing.

But the placement of alcohol-based hand sanitizer for health workers isn’t as convenient as it could be, reducing its use. The reason? In the early 2000s, fire marshals began requiring hospitals to remove or relocate dispensers because hand sanitizers contain at least 60 percent alcohol, making them flammable.

Fire codes now limit where they can be placed — a minimum distance from electrical outlets, for example — or how much can be kept on site.

Hand sanitizers are most often used in hallways, though greater use closer to patients (like immediately before or after touching a patient) could be more effective.

. . .

Although there have been fires in hospitals traced to alcohol-based hand sanitizer, they are rare. Across nearly 800 American health care facilities that used alcohol-based hand sanitizer, one study found, no fires had occurred. The World Health Organization puts the fire risk of hand sanitizers as “very low.”

For the full commentary, see:

Frakt, Austin. “Lab Coat Can Host Dangerous Bacteria.” The New York Times (Tuesday, April 30, 2019): A11.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date April 29, 2019, and has the title “Why Your Doctor’s White Coat Can Be a Threat to Your Health.” The last two sentences quoted above, occur in the online, but not the print, version of the article.)

The the rarity of hand sanitizer hospital fires was documented in:

Boyce, John M., and Michele L. Pearson. “Low Frequency of Fires from Alcohol-Based Hand Rub Dispensers in Healthcare Facilities.” Infection Control & Hospital Epidemiology 24, no. 8 (Aug. 2003): 618-19.

$15 Minimum Wage Equals Income About Twice Federal Poverty Level for Household of Two

(p. B1) The legal minimum wage in the United States is $7.25 per hour, . . .

The minimum wage roughly meshes with federal poverty guidelines. According to the guidelines, a two-person household with a total annual income below $16,910 is considered to be living in poverty. To clear the poverty line, one of those two people would have to make $8.13 an hour or more. At least 17 states have minimum wages higher than that. The $15-per-hour minimum wage in New York City, for example, translates to an annual income of $31,200, which is almost twice the federal poverty level for a household of two.

For the full story, see:

Eric Ravenscraft. “Do You Earn a ‘Living Wage’? Cut Through the Confusion.” The New York Times (Saturday, June 8, 2019): B1 & B5.

(Note: ellipsis added.)

(Note: the online version of the story has the date June 5, 2019, and has the title “What a ‘Living Wage’ Actually Means.”)

Cost of Housing Is Main Driver of Migration from Superstar Cities

(p. B1) Last month the Census Bureau confirmed a confounding dynamic taking hold across the American landscape: Superstar cities, the nation’s economic powerhouses, hotbeds of opportunity at the cutting edge of technological progress, are losing people to other parts of the country.

For the first time in at least a decade, 4,868 more people left King County, Wash. — Amazon’s home — than arrived from elsewhere in the country.

Santa Clara County, Calif., home to most of Silicon Valley, lost 24,645 people to domestic migration, its ninth consecutive annual loss.

The trend is becoming widespread. Eight of the 10 largest metropolitan areas in the country, including those around New York, San Francisco, Los Angeles and Miami, lost people to other places in 2018. That was up from seven in 2016, five in 2013 and four in 2010. Migration out of the New York area has gotten so intense that its total population shrank in 2018 for the second year in a row.

. . .

(p. B5) Research by Peter Ganong from the University of Chicago and Daniel Shoag of Harvard suggests that housing costs are a principal driver of the change in migration decisions: As the highly educated have flocked to superstar cities, they have pushed housing prices way beyond the reach of people earning less. Continue reading “Cost of Housing Is Main Driver of Migration from Superstar Cities”

Modi Cut India’s Taxes, Corruption, and Regulations

(p. B1) MUMBAI, India — A jeans maker saw his delivery costs cut by half when the highway police stopped asking for bribes. An aluminum wire factory faced only three inspectors rather than 12 to keep its licenses. Big companies like Corning, the American fiber-optic cable business, found they could wield a new bankruptcy law to demand that customers pay overdue bills.

Prime Minister Narendra Modi promised nearly five years ago to open India for business. Fitfully and sometimes painfully, his government has streamlined regulations, winnowed a famously antiquated bureaucracy and tackled corruption and tax evasion.

. . .

(p. B5) Mehta Creation, a jeans maker in a dilapidated concrete building in the northern outskirts, paid a welter of taxes until two years ago. That included the dreaded octroi, a British import from medieval times that allowed states and some cities to collect taxes whenever goods crossed a boundary.

Mehta Creation’s budget was contorted by corruption. To avoid the octroi, which could triple the cost of a delivery and add delays, Mehta paid drivers about $5 for each parcel of jeans and then reimbursed them up to $6 per parcel to bribe the local police at every border, said Dhiren Sharma, the company’s chief operating officer.

Mehta’s costs dropped after the government abolished 17 taxes, including the octroi, two years ago and established instead a national value-added tax on most business activity. Continue reading “Modi Cut India’s Taxes, Corruption, and Regulations”

Mayor de Blasio Seeks “Ban” on “Glass and Steel Skyscrapers”

(p. A23) As he stood on the Queens shoreline on Earth Day, Mayor Bill de Blasio issued a stern warning that the familiar Manhattan skyline behind him was about to change.

“We are going to introduce legislation to ban the glass and steel skyscrapers that have contributed so much to global warming,” he said on Monday. “They have no place in our city or on our Earth anymore.”

. . .

“Everyone is trying to figure out what the mayor meant,” said Adam Roberts, director of policy for the American Institute of Architects New York. “We just hope that the mayor misspoke.”

For the full story, see:

Jeffery C. Mays. “Mayor’s ‘Ban’ of Glass and Steel Skyscrapers? Not Quite That Harsh.” The New York Times (Friday, April 26, 2019): A23.

(Note: ellipsis added.)

(Note: the online version of the story has the date April 25, 2019, and has the title “De Blasio’s ‘Ban’ on Glass and Steel Skyscrapers Isn’t a Ban at All.” The online version says that the New York Edition print version had the title “A Ban on Glass and Steel? ‘Perhaps the Mayor Was Overenthusiastic’.” My National Edition print version had the title “Mayor’s ‘Ban’ of Glass and Steel Skyscrapers? Not Quite That Harsh.”)

New York City Made $855 Million Selling Over-Priced Taxi Medallions to Trusting Immigrants

(p. A1) At a cramped desk on the 22nd floor of a downtown Manhattan office building, Gary Roth spotted a looming disaster.

An urban planner with two master’s degrees, Mr. Roth had a new job in 2010 analyzing taxi policy for the New York City government. But almost immediately, he noticed something disturbing: The price of a taxi medallion — the permit that lets a driver own a cab — had soared to nearly $700,000 from $200,000. In order to buy medallions, drivers were taking out loans they could not afford.

. . .

Medallion prices rose above $1 million before crashing in late 2014, wiping out the futures of thousands of immigrant drivers and creating a crisis that has continued to ravage the industry today. Despite years of warning signs, at least seven government agencies did little to stop the collapse, The New York Times found.

Instead, eager to profit off medallions or blinded by the taxi industry’s political connections, the agencies that were supposed to police the industry helped a small group of bankers and brokers to reshape it into their own moneymaking machine, according to internal records and interviews with more than 50 former government employees.

For more than a decade, the agencies reduced oversight of the taxi trade, exempted it from regulations, subsidized its operations and promoted its practices, records and interviews showed.

Their actions turned one of the (p. A20) best-known symbols of New York — its signature yellow cabs — into a financial trap for thousands of immigrant drivers. More than 950 have filed for bankruptcy, according to a Times analysis of court records, and many more struggle to stay afloat.

“Nobody wanted to upset the industry,” said David Klahr, who from 2007 to 2016 held several management posts at the Taxi and Limousine Commission, the city agency that oversees cabs. “Nobody wanted to kill the golden goose.”

New York City in particular failed the taxi industry, The Times found. Two former mayors, Rudolph W. Giuliani and Michael R. Bloomberg, placed political allies inside the Taxi and Limousine Commission and directed it to sell medallions to help them balance budgets and fund priorities. Mayor Bill de Blasio continued the policies.

Under Mr. Bloomberg and Mr. de Blasio, the city made more than $855 million by selling taxi medallions and collecting taxes on private sales, according to the city. Continue reading “New York City Made $855 Million Selling Over-Priced Taxi Medallions to Trusting Immigrants”

Due to “Safety” Regulations, Disabled Man Crawls Up Airplane Stairs

(p. B4) The activist, Hideto Kijima, said Vanilla Air staff initially told him he would not be allowed to board the small aircraft, which was flying from a small airport on the southern island of Amami to Mr. Kijima’s home in Osaka, because it lacked wheelchair-accessible boarding ramps or elevators.

Mr. Kijima was paralyzed from the waist down while playing rugby as a teenager and now uses a wheelchair.

. . .

He was visiting the island with a group of friends, and they offered to carry him up the short stairway from the tarmac, he said. But the airline told them that would violate safety regulations.

So he started crawling.

“I sat down on the stairs and started climbing up one at a time,” he wrote. “The staff told me to stop but I ignored them. How else was I supposed to get back to Osaka?”

He was allowed to take a seat once he reached the top, he said.

For the full story, see:

Jonathan Soble. “Airline Apologizes to Disabled Man Who Crawled His Way Onto Plane.” The New York Times (Friday, June 30, 2017): B4.

(Note: ellipsis added.)

(Note: the online version of the story has the date June 29, 2017, and has the title “Japanese Airline Apologizes After Disabled Man Crawls Aboard.”)

“You Don’t Venture into the Wilderness Expecting to Find a Paved Road”

(p. 40) I, . . . , always considered the heart a pump, much the way a doctor explained it to Sandeep Jauhar during his cardiology fellowship. “In the end,” the doctor said, “cardiology is mostly a problem of plumbing.”

Jauhar quickly learned otherwise. His gripping new book, “Heart: A History,” had me nearly as enthralled with this pulsating body part as he seems to be. The tone — a physician excited about his specialty — takes a sharp turn from his first two memoirs. The first, “Intern,” was filled with uncertainty; the second, “Doctored,” with disillusionment.

. . .

We go into an operating room where a young girl is having open-heart surgery, tethered to a heart-lung machine. Then we learn that the concept for this machine began with one doctor’s brazen idea of connecting a patient to another person’s blood supply. He was inspired by the way a fetus feeds off its mother. Six of seven cases ended with a death.

Eventually, the heart-lung machine replaced the volunteers. The machine got off to a rough start too: 17 of the first 18 patients died. As one of the mid-20th-century researchers remarked, “You don’t venture into the wilderness expecting to find a paved road.”

Continue reading ““You Don’t Venture into the Wilderness Expecting to Find a Paved Road””